Lot Release Testing

M-700 FDA Points to Consider Method

This test satisfies the FDA Points to Consider for the Mycoplasma testing of Cell Cultures and Biologicals derived from cell substrates. The procedure is recommended for each lot of product harvest concentrate and the master cell banks, working cell stocks and cell substrates used for the manufacturing of these products. This method consists of the...

  • Total Testing Time: 28 days
  • Sample Requirements: Minimum Test Volume 15 mL
  • GMP Service

M-800 Mycoplasma Test for Human Vaccines and Biologicals Compliance with 21 CFR 610.30

The purpose of Bionique’s M-800 Mycoplasma Test is to detect the presence of agar cultivable and non-cultivable mycoplasma species in viral vaccines produced in cell substrates and similar products. The test is also recommended for virus seed stocks, master / working cell banks, cells substrates, and other biological products produced in cell...

  • Total Testing Time: 28 days
  • Sample Requirements: Minimum Test Volume = 12 mL Test Article and 12 mL of Control Fluid
  • GMP Service

M-1000 Mycoplasmastasis Validation Study

Bionique® offers Mycoplasmastasis studies to validate our M-700 or M-800 Assay for an individual test article. The qualification study is designed to determine the presence or absence of product-specific inhibition of mycoplasma growth within our assays. This test is recommended only once for any given final product unless changes within...

M-1400 Harmonized USP <63> Mycoplasma Test

Bionique’s M-1400 Harmonized USP Mycoplasma test was designed to comply with USP chapter Mycoplasma Tests, European Pharmacopoeia (Ph. Eur.) chapter 2.6.7 Mycoplasma, and the United States FDA’s 1993 Points to Consider in the Characterization of Cell Lines Used to Produce Biologicals (PTC) requirements.

  • Total Testing Time: 28 days
  • Sample Requirements: Minimum Test Volume = 15 mL
  • GMP Service

M-1450 Inhibition Testing for the Harmonized USP <63> Mycoplasma Test

The M-1450 Test is designed to determine the presence or absence of product-specific inhibition of mycoplasma growth within the Bionique's Harmonized USP  assay.

  • Total Testing Time: 28 days
  • Sample Requirements: Minimum Test Volume = 45 mL
  • GMP Service
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Specializing In

Real-Time PCR Testing

Bionique has optimized the MycoSEQ Real-Time PCR Detection Assay for mycoplasma testing.

PCR Testing Services Harmonized USP Testing